transcript   Transcript

Life Sciences Industry Under the New Trump Administration

Recorded on: Mar. 10, 2017
Running Time: 01:04:10

Full Transcript:

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Taken from the briefing Life Sciences Industry Under the New Trump Administration recorded March, 2017 in New York.

What lies ahead for the life sciences industry under the new Trump Administration? Despite plenty of uncertainties at this early stage, important Executive Branch guidance and regulations were released in the final weeks of the Obama Administration and clients still need to be educated on the effects of the annual updates to the Medicare Part D Prescription Drug program.

Lecture Topics  [01:04:10]

Listen to Susan Kornetsky, J.D. (former Director, Federal Reimbursement at Sanofi US) and Jayson S. Slotnik, J.D. (Partner, Health Policy Strategies, Inc.) as they address:

  • FDA draft guidance on off-label promotion
  • Medicare program guidance, including the 2018 Draft Medicare Advantage and Part D Payment Policies and Call Letter; Direct and Indirect Remuneration (DIR); and new anti-kickback safe-harbors affecting prescription drugs
  • The HRSA final rule on “penny-pricing” and price reporting, the "340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation"
  • Potential legal, legislative and regulatory developments that could impact manufacturers

Presentation Material

  • Life Sciences Industry under the New Trump Administration
    Susan Kornetsky, Jayson S. Slotnik
Susan Kornetsky ~ Vice President, Entree Health
Jayson S Slotnik ~ Health Policy Strategies, Inc.
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